Bellvitge University Hospital
🇪🇸Spain
RapidPulse Initiates Patient Enrollment in Pivotal IDE Study for Novel Ischemic Stroke Treatment
• RapidPulse has begun enrolling patients in an IDE study across Spanish hospitals to evaluate its cyclic aspiration system for acute ischemic stroke treatment, with plans to expand to 30 sites across the U.S. and Europe.
• Previous studies demonstrated the RapidPulse system achieved first-pass full reperfusion rates of 60-69%, significantly higher than the 40-42% rates typically observed with current-generation devices.
• Upon completion of the pivotal study, data will be submitted to the FDA for 510(k) clearance, potentially transforming standard treatment approaches for the estimated 700,000 annual ischemic stroke cases in the U.S. alone.
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